Real-World Evidence Data on Adverse Reactions to Infusion of Thawed Hematopoietic Progenitor Cells: Retrospective Analysis from a Single Center in India

Abstract

Introduction Adverse reactions (ARs) occur during infusion of thawed hematopoietic progenitor cells (HPCs) either due to infusion or its contents. There is sparse literature on it in the world and none in India. Therefore, we retrospectively analyzed ARs occurring during and within 1 hour of infusion of thawed HPCs.

Objective This study aimed to evaluate the prevalence of adverse reactions associated with the infusion of cryopreserved hematopoietic progenitor cells (HPC) and to categorize the types of adverse reactions observed in HPC transplant recipients during its infusion.

Materials and Methods This study was done in a tertiary-care center, between 2019 and 2022. Data collected included age, gender, diagnosis, specifications of contents of infusion product (volume of product, volume of dimethyl sulfoxide per kg body weight, total nucleated cell count per microliter, and viability of CD 34+ cells), pretreatment given, and ARs, if any from the procedure records and the hospital information system.

Results The present study included 55 transplant patients, and the commonest diagnosis was Hodgkin lymphoma. All were prophylactically hydrated and premedicated as per institutional protocol. AR was seen in 56.36% (n = 31); the commonest type of ARs was nausea (n = 26) followed by vomiting (n = 13), abdominal pain (n = 4), shivering (n = 3), transient tachycardia (n = 2), transient hypotension (n = 2), and hematuria (n = 1). All ARs were managed clinically by giving symptomatic treatment. No patients required intensive care, and there were no deaths or aborted procedures. Characteristics of infusion products had no significant correlation to ARs.

Conclusions To the best of the author's knowledge, this is the first such study from India. We report an overall incidence of ARs of 56.36%, which is similar to the previously published data on ARs during thawed HPC infusions. AR is a common occurrence and can be managed medically and symptomatically.

Keywords

adverse reactions - infusion - transplant - hematopoietic progenitor cell

Note

The manuscript has been read and approved by all the authors and the requirements for authorship have been met. Each author believes that the manuscript represents honest work.

Author's Contributions

A.K.T. conceptualized and designed the study protocol, screened eligible studies previously published and analyzed the data. G.A. and S. Pabbi contributed to writing the report, analyzing data, and interpreting the results. S. Pawar, S. Golia, and S. Gupta contributed to extracting data from the procedure sheet and HIS, writing the report, and updating the reference lists. G.R. provided technical support during the conduct of the study. N.S. and S.Y. contributed to manuscript editing and review. All authors reviewed and approved the final manuscript.

Patient Consent

Informed consent was obtained from each patient before commencing treatment. Patient identifiers were removed and complete confidentiality was maintained. There was no study-specific consent since anonymised data was used for this observational analysis. Institutional review board (IRB) gave a waiver for study-specific consent.

Publikationsverlauf

Artikel online veröffentlicht:
22. Juli 2024

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